JP2017511193A - Inhalation training apparatus and system for training inhalation process of patient - Google Patents

Abstract

The present invention relates to an inhalation training apparatus and an inhalation training system for training a patient's inhalation process. This inhalation training device includes a housing that can be attached to and detached from an inhaler mouthpiece designed to deliver medication to a patient, and a mouthpiece in the inhaler during the patient inhalation process. And a microphone adapted to measure the airflow generated in the. The inhalation training system includes an inhalation training device, an inhaler, and an electronic device configured to evaluate a signal received from the inhalation training device and provide visual and / or audio feedback to the patient. [Selection] Figure 1

Description

  The present invention relates to an inhalation training device for training a patient's inhalation process and an inhalation training system for training the patient's inhalation process.

  Inhaled drugs constitute a preferred therapy for patients with asthma, chronic obstructive pulmonary disease, or other chronic or acute airway conditions or diseases.

  A so-called inhaler is used for inhalation of medicine. The most frequently used inhalers are the pressurized metered dose inhaler (pMDI) and the powder inhaler (DPI). pMDI was developed to deliver the exact drug amount or dosage to the patient's lungs in the form of cloud aerosol droplets upon inhalation by the patient. Powder inhalers are designed to deliver a fixed amount of dry fines particles to the lungs upon inhalation by the patient.

  For example, WO 2008/151796 shows another inhaler. This inhaler delivers a metered amount of drug as a slow moving soft mist through a nozzle system without the use of propellants.

  The effect of the inhaled drug mainly depends on how the patient uses the inhaler. It is optimal that the correct amount of drug migrates to the desired lung region at the correct time. Otherwise, the therapeutic effect is reduced and / or the risk of adverse effects is increased.

  This document contains numerous examples that demonstrate that many patients are not using inhalers correctly. Patient guidance on correct inhalation can improve inhaler use. For this purpose, practical training is useful in addition to written and oral guidance.

  However, it is particularly difficult for patients to change their inhalation in order to enhance the effectiveness of the inhaled drug, since inhalation is generally performed unconsciously and is habituated for a lifetime. Rather, it has been found that many patients again use suboptimal inhalation, even after a short period of instruction. Therefore, it is preferable to practice inhalation and checking iteratively, preferably regularly (specifically, as a synonym for training).

  An inhalation training system was developed for this purpose. Known inhalation training systems include, among other things, the inhalation model in which the patient is to be trained, the type of feedback to the patient (eg, acoustic or visual), the variable being measured (eg, the inhalation volume, the volumetric flow rate that occurs during inhalation, The flow rate or mass flow, the velocity of the particles inhaled during the inhalation process), the sensors and actuators (eg mechanical, magnetic or electronic) and the size, handling and cost are different. Some inhalation training systems use commercially available inhalers, while others copy or imitate inhalers or parts thereof.

  European Patent No. 1,993,642, which forms the starting point of the present invention, shows an inhalation training device for training a patient's inhalation process. This known inhalation training device includes a housing that can be attached to and detached from an inhaler mouthpiece designed to deliver medication to a patient, and an inhaler mouse during the inhalation process of the patient. And a microphone adapted to measure the air flow generated in the piece. The known inhalation training device may further comprise data communication means for communicating with a computer or device adapted to transfer information from the monitoring device to a doctor or other person for analysis and evaluation. it can.

International Publication No. 2008/151796 European Patent No. 1993642 International Publication No. 1996/006011 International Publication No. 2009/115200 European Patent No. 2614848

  The object of the present invention is to provide an inhalation training device and an inhalation training system and / or a simple, reliable, comfortable, and / or cost effective patient inhalation training. To provide a cost-effective, robust and / or regulatory-compliant structure and / or accurate measurement of the flow generated by the patient during training and / or patient-friendly real-time feedback .

  This object is achieved by an inhalation training device according to claim 1 or an inhalation training system according to claim 12. Preferred embodiments of the invention are the subject matter of the dependent claims.

  According to one aspect of the invention, the housing of the inhalation training device is comprised of two housing parts that are snapped together during assembly of the housing. The two housing parts are two simple mechanical parts designed to fit the mouthpiece of the inhaler. Thus, a rugged and cost-effective unit that fits securely on the mouthpiece is formed with the shortest tolerance chain, thereby minimizing leakage between the exact microphone position, the mouthpiece of the inhaler and the housing of the inhalation training device To ensure the best performance in terms of optimization, which supports the measurement accuracy and ultimately the mechanical stability. Furthermore, the housing has enough space inside to accommodate and protect the microphone, additional electronics and cables.

  The inhalation training device claimed in the present invention enables effective, comfortable and reliable training of the inhalation process.

  Both housing parts are preferably made of molded plastic with a smooth surface, specifically acrylonitrile butadiene styrene (ABS). This embodiment allows a cost-effective structure and reduction of handling noise caused by a patient training the inhalation process, for example, by stroking or scratching on the inhalation training device. This embodiment thus allows for higher measurement accuracy.

  The measurement accuracy can be further increased by at least partially covering both housing parts with a low friction layer, specifically glossy chrome. It has been found that there can be as much as 15 dB of frictional noise difference between a smooth ABS surface and the same surface coated with shiny chrome.

  The housing preferably includes a molded parting line so that it can be hermetically attached to the mouthpiece of the inhaler. This embodiment allows for reliable inhalation process training, rugged construction and accurate flow measurement.

  According to another aspect of the present invention, when the microphone attaches the inhalation training device to the mouthpiece of the inhaler, in the housing, outside the mouthpiece of the inhaler, near the air hole of the mouthpiece of the inhaler. Located in. This allows accurate flow measurement without the need to intervene in the function of the inhaler or to change the design of the inhaler. In this embodiment, the aerodynamic behavior of the inhaler flow path does not change. In this way, the medical adaptability of the inhaler is not affected by the presence (or absence) of the inhalation training device.

  The housing preferably includes a pad and / or sleeve around the microphone, specifically made of foamed plastic or soft silicone. This improves the insulation of the microphone and reduces the vibration coupling from the inhalation training device into the microphone. This further reduces handling noise and improves flow rate measurement accuracy.

  The microphone is preferably an electret microphone.

  The microphone is preferably adapted to measure noise in the airflow through the air holes of the mouthpiece of the inhaler. In acoustics, it is well known that sound is transmitted well in most solid materials. When a patient performs inhalation using an inhaler, the flow path in the inhaler generates a characteristic flow noise sound according to the flow rate and turbulent flow. Part of this sound is transmitted through the solid structure of the inhaler. Since solid materials have low loss, this sound can be detected in principle anywhere on the inhaler surface. A preferred embodiment of measuring airflow noise through the air holes of the inhaler mouthpiece allows for effective and reliable training and accurate flow measurement during training.

  The microphone preferably exhibits directivity, specifically, cardioid, super cardioid, hypercardioid, or bidirectional characteristics. The characteristics of the directional microphone make it possible for the microphone itself to invalidate signals originating from the outside of the mouthpiece of the inhaler, but not affecting sound originating from the inside. Therefore, the influence of ambient noise during training can be reduced and the flow measurement accuracy can be increased.

  The inhalation training device preferably provides an interface with the electronic device. The electronic device is preferably a portable communication device that can capture, transmit and / or output information and can be easily carried by an individual. Typical applications for portable communication devices are phone calls, data transmission, games, document processing, table processing, image processing, photography and music playback. Typical examples of portable communication devices are mobile phones, smartphones, tablet PCs, handheld devices and PDAs.

  In this embodiment, the signal measured by the microphone of the inhalation training device, in particular, is processed and / or evaluated and / or the patient and / or third party in a simple, intuitive, reliable and cost effective manner. In order to provide feedback, the function of the electronic device can be utilized. At the same time, in this embodiment, the functionality of the electronic device can be extended in a simple and cost-effective manner for training the patient's inhalation process.

  As a result of the widespread use of portable communication devices, access to inhalation training can also be provided to patients who do not wish to purchase a special electronic device just for inhalation training. Since owners of portable communication devices are accustomed to handling portable communication devices, the embodiments claimed in the present invention also allow easier and faster learning of the optimal inhalation process. Since many individuals always carry portable communication devices, the embodiments claimed in the present invention are frequent and in some cases can provide regular inhalation training. Furthermore, the embodiments claimed in the present invention increase ease of operation and ease of inhalation training.

  Specifically, the interface to the electronic device is realized by an audio jack, in particular a 3.5 mm TRRS headphone connector. Audio jack is a generic term for a family of connectors typically used for analog audio signals. Usually, audio jacks are typically cylindrical with two, three or four contacts. The 4-contact version is known as a TRRS connector, where T represents “tip”, R represents “ring”, and S represents “sleeve”. Three standard sizes are available for modern audio jacks: 6.35 mm, 3.5 mm and 2.5 mm.

  The 3.5mm TRRS headphone connector is the world's most common connector for portable communication devices, so the proposed embodiment is compatible with a wide range of portable communication devices, and the inhalation training device requires only one variation Make sure you don't. The proposed embodiment enables comfortable and cost-effective training of the patient's inhalation process and patient-friendly real-time feedback.

However, even though manufacturers agree on the physical format of the 3.5mm TRRS headphone connector, they disagree on various details related to the interface connection of electronic devices. One of the most fundamental differences is the polarity of the microphone connection, such as Apple's device family and Samsung, HTC, LG, Sony, Motorola, Microsoft, Blackberry, and Nokia. Different from most other manufacturers. The following table shows a typical connection scheme.

  The inhalation training device preferably includes an electronic device configured to replace the electrical connection with a microphone and ground according to the TRRS headphone connector connection scheme. Specifically, different polarities of the microphone connection are automatically processed using an analog electronic switch located at the connection between the microphone and the TRRS headphone connector. In particular, the associated switching is directly selected using the microphone bias voltage (i.e., the positive voltage at the microphone connection), thus switching between microphone connection and ground connection as needed. Such analog switching results in excellent audio characteristics and very limited resistance well below 1 ohm.

  In addition to the polarity of the microphone connection, there is also a slight difference in how and when a particular portable communication device recognizes that an external connection has been established in relation to the impedance level between the microphone and the ground connector. is there.

  The inhalation training device preferably includes an electronic device configured to adjust the frequency range in which the microphone operates as a function of the analog front end sensitivity of the electronic device. To assess airflow, the noise induced by the flow, measured by the microphone of the inhalation training device, should be analyzed, and this usually means that the sound pressure level (eg within a selected frequency band) Is converted to a constant sound pressure level, and then the appropriate flow level is determined using the established correlation pattern between noise and flow. However, this process assumes well-defined acoustic characteristics of the electronic device, specifically analog front end sensitivity and linearity, and (for broadband signals) frequency range and linearity.

  Typically, electronic devices filter the frequency range of 200 Hz to 20000 Hz to deal with high quality audio. From the perspective of the inhalation training device, turbulent noise generally has a broadband noise profile over a frequency of at least 100 Hz to 10000 Hz, but usually the flow signal is for example 500 Hz to 1000 Hz (depending on the type of inhaler among others). Good transmission in a narrow band. Therefore, in a preferred embodiment of the inhalation training device, the frequency range in which the microphone operates can be adjusted according to the acoustic characteristics of the electronic device, specifically the analog front end sensitivity thereof.

  For amplification linearity, it is preferred that the inhalation training device target the normal speech amplitude range to make it less likely to cause potential (unknown) compression. However, the inhalation training device electronics can be adjusted to stay within the linear region of most restricted electronic devices, thereby ensuring a sufficiently uniform electronic device interface to all selected electronic devices. become.

  The inhalation training device preferably includes an electronic device configured to generate a reference sound during training. Therefore, this reference sound always occurs with the microphone signal and makes available a known reference. This reference sound is realized by implementing a clearly defined frequency and amplitude oscillator (eg, about 10 kHz) in the inhalation training device electronics and mixing the reference sound with the microphone signal.

  The reference tone oscillator is preferably configured around a low voltage operational amplifier and a precision voltage controller that defines an amplitude of 1.2V.

  The inhalation training device housing may be designed to prevent mispositioning of the housing (eg, up / down and / or right / left rotation from the correct position) when attached to the mouthpiece of the inhaler. preferable.

  According to another aspect of the invention, the housing is designed to prevent drug release and / or any fluid dispensing during training. Specifically, when the inhalation training device is attached to the mouthpiece of the inhaler, a part of the housing of the inhalation training device covers the drug release actuator of the inhaler. This embodiment ensures that the inhalation training device complies with regulatory requirements such as the EU Medical Device Directive (MDD / 93/42 / EEC) and US Medical Device Guidelines (FDA 21 CFR Part 820).

  Another aspect of the invention relates to an inhalation training system for training a patient's inhalation process. According to this embodiment, an inhalation training system evaluates signals received from an inhalation training device, an inhaler, and an inhalation training device according to one or more of the aspects described above, and provides visual and And / or an electronic device configured to provide audio feedback.

  This inhalation training system is effective, simple, reliable, comfortable and cost-effective training of the patient's inhalation process, accurate measurement of the flow generated by the patient during training, and patient-friendly real-time feedback Enable.

  The inhalation training system is preferably configured to detect the presence of patient exhalation during training. If a patient unintentionally exhales into the inhaler mouthpiece during training, this can unduly enhance false or inefficient patient behavior. Thus, by detecting the presence of the patient's exhalation during training, it is possible to effectively train the patient's inhalation process.

  Measurements of inspiratory or expiratory flow and extraction of the frequency spectrum of each individual flow level separately for inspiratory and expiratory results showed that inspiratory flow generally produces a flatter spectral response compared to expiratory flow. . This means that when calculating the ratio between the low frequency energy content and the high frequency energy content, the exhaled breath will have a greater ratio than inspiration. Inhalation training systems take advantage of this relationship by defining a suitable threshold that separates these two frequency clusters. For example, when the content of a low frequency signal is evaluated using a 300 Hz filter and the content of a high frequency signal is evaluated using a 7000 Hz filter, a threshold value of 70 is inhaled and expired at a low flow rate of about 10 to 30 l / min. Was confirmed to be well separated.

  However, as the flow rate increases, the inspiratory and expiratory spectral curves tend to be more similar to each other, i.e., this separation is not sensitive at high flow rates. To deal with this situation, it is based on another characteristic trend of the above flow sound spectrum, i.e., the tendency that the expiratory sound spectrum reaches a higher level than the complementary inspiratory sound spectrum in the low frequency region. Adopt a queue. Based on this observation, a further indicator that represents the presence of expiratory airflow is low frequency signal energy. The inhalation training system preferably determines that expiration has been detected when the low frequency signal energy exceeds a threshold of 7. This threshold provides adequate separation between inspiration and expiration at high flow rates of about 50-90 l / min.

  The preferred threshold definition is to have a high degree of detection specificity, i.e. with the express purpose that the inhalation training system should not give a warning about exhalation while the patient is actually inhaling correctly. It was.

  The electronic device of the present invention is preferably configured to detect the presence of a characteristic audio signal in the signal received from the inhalation training device. Usually, the human voice does not have a flat acoustic spectrum, but rather consists of a series of equally spaced peaks and valleys starting from the lowest formant frequency. The electronic device can be configured to temporarily interrupt the flow evaluation if the signal received from the inhalation training device is biased to such a characteristic audio signal or spectrum. Therefore, robustness against the influence of voice is improved.

  The electronic device is preferably configured to detect the presence of an inhalation training device and / or a particular type of inhaler, specifically by reference sounds produced by the inhalation training device during training. For this purpose, the reference sound produced by the inhalation training device as described above is used to ensure that the inhaled training device specifically claimed is plugged into the electronic device via an interface (3.5 mm TRRS headphone connector). Can be detected automatically. Otherwise, the electronic device can be configured not to provide feedback regarding flow detection.

  The electronic device is preferably a portable communication device that can capture, transmit and / or output information and can be easily carried by an individual. Typical examples of portable communication devices are mobile phones, smartphones, tablet PCs, handheld devices and PDAs. Electronic devices within the scope of the present invention are devices that are separate or independent of the inhalation training device.

  The electronic device is preferably designed to store and output the measured, processed and / or evaluated signals and / or to provide bi-directional feedback to the patient and / or a third party. Specifically, the electronic device comprises a device for acoustically feeding back the evaluation, for example a speaker, and / or a visual feedback of the evaluation, for example a screen.

  The electronic device can specifically provide instructions for correct inhalation and / or advice for optimization. The electronic device can further display photographs and / or videos showing the optimal inhalation process for more effective training of the patient.

  The term “bidirectional” means a characteristic that makes available to the patient the possibility of intervention and control for individual learning. To do this, for example, the choice of information and the type of representation can be adapted to the patient's prior knowledge, interests and needs, or can be manipulated by the patient. In the present invention, merely making information available does not constitute interactive feedback.

  The electronic device is preferably designed to wirelessly transmit the measured, processed and / or evaluated signal to another electronic device. In this way, for example, a signal can be sent to the doctor, who can prepare diagnostic results based on this signal and / or give advice to improve the inhalation process.

The electronic device is preferably designed or can be used to practice the best possible effective inhalation time T _{in, eff} as possible. In this way, the patient can achieve the best effective inhalation time possible. The effective inhalation time is the time during inhalation of the inhalation training process, in particular the simulated inhalation time that simulates the delivery of a drug amount or dosage. Specifically, the effective inhalation time is the time portion where the dose inhalation and the simulated delivery overlap.

  Based on this effective inhalation time, the inhalation dosage (iDoD) can be estimated. This iDoD applies particularly when the drug is delivered at a generally constant rate. Inhalation dosage can be obtained as a percentage of the delivered dosage. Effective inhalation time and inhalation dosage represent the quality of the inhalation process.

  The electronic device is preferably designed to determine an effective inhalation time in order to practice an effective inhalation time. The electronic device can determine the delivery time or nebulization time to determine the effective inhalation time. Delivery time or spray time is the time that simulates the delivery of a dosage. The end of delivery is preferably fixed by a constant delivery duration or spray duration (SDur). The effective inhalation time is preferably obtained as a percentage of the spray duration.

In one preferred embodiment, the effective inhalation time is 0% if the delivery time is outside the inhalation process or time of inhalation (T _in ), ie if the delivery time has passed before the start of the inhalation process. In this embodiment, if the delivery time is completely within the time of the inhalation process, the effective inhalation time is 100%.

If delivery begins before the start of the inhalation process and ends after the end of the inhalation process, the effective inhalation time is preferably determined according to the following formula:
T _{in, eff} [%] = T _in * 100 / SDur

If delivery is started after the inhalation process starts but before the end, and after the inhalation process ends, the effective inhalation process is preferably determined according to the following equation:
T _{in, eff} [%] = (1− (Δ + SDur−T _in ) / SDur) * 100
Δ is the difference between the start of the delivery and the start of the inhalation process, ie Δ has a positive value if the delivery is started after the start of the inhalation process and the delivery is started before the start of the inhalation process. If started, Δ is negative.

If the delivery is started before the start of the inhalation process and the delivery ends after the start of the inhalation process and before the end, the effective inhalation process is preferably determined according to the following formula:
T _{in, eff} [%] = (Δ + SDur) / SDur * 100
Δ is the difference between the start of delivery and the start of the inhalation process.

Specifically, in determining the effective suction time it can be regarded only intake time and intake time T _in. Thus, if inspiration is interrupted by stopping breathing or expiration, these times are preferably deducted from the inhalation time.

  Alternatively or additionally, the electronic device can be designed to determine or estimate the volumetric flow rate or flow rate generated during the inhalation process and / or the flow rate generated here. These two physical quantities are highly representative of the quality of the inhalation process.

  The electronic device can also be designed to determine or estimate the flow rate. It has been found that the rate of drug inhaled depends on where the drug should be placed (throat, lungs). Therefore, flow rate can be a concern in determining whether inhalation was correct. The electronic device should also determine or estimate the time that flow has been within a certain flow rate interval or above a certain lower limit to ensure that inhalation was adequate or sufficient. It can also be designed.

  Inhalation training is preferably performed with the assistance of software adapted to the electronic device, which can be specifically ordered and installed via an online portal. This software is usually called an “app”. By using the app, flexibility and operability are improved.

  The app can be used, for example, for processing and interpretation of measured signals and for feedback to patients and / or third parties. To do this, the app can be made available or executed using an information storage medium. The information storage medium is preferably made for use in a portable communication device and is particularly optimized with respect to space requirements, energy consumption, reliability and data transmission rate.

  Hereinafter, preferable steps of the application will be described.

  In a preferred step of the app, the app is started in the first step. In subsequent steps, a graphical user interface (GUI) is activated and preferably displayed on the screen of the electronic device. Specifically, a visual start instruction or a visual trigger instruction is also displayed.

  In another step, for example, to display the contents of the changed GUI, the loop function is started using the application with the updated GUI.

  The start instruction or the trigger instruction is preferably evaluated using an application. Specifically, the operation of the start instruction or trigger instruction by the user or patient, particularly the user or patient, is monitored. It is preferable to determine whether the start instruction or trigger instruction has been activated by monitoring the input. If it is determined that the start instruction or trigger instruction has been activated, the app preferably follows two parallel branches.

  On the one hand, in the first branch, it is preferable to monitor whether a visual stop instruction has been activated (especially on the screen). This monitoring preferably determines whether or not the stop instruction has been activated. On the other hand, in a second branch parallel to the monitoring of the stop indication, one or more electrical signal values received from the inhalation training device are read out. The app or electronic device preferably causes processing of the electrical signal values, in particular digitization and storage of the electrical signal values.

  In another step within the second branch, the volumetric flow or flow produced during the inhalation process is determined and / or the flow profile is prepared using an app or electronic device.

  Within the second branch, the start of the inhalation process is preferably monitored by an app or electronic device. This monitoring preferably determines whether the inhalation process has started. Here, it is preferable that the application or the electronic device is designed so that the operation of the trigger instruction is interpreted as the start of the inhalation process, thereby determining that the inhalation process has started.

  If it is determined that the inhalation process has started, on the one hand, it is preferred that the start time is specified by the app or the electronic device. Moreover, it is preferable that a further time value can be specified by the application or the electronic device via the time keeper.

  If it is determined that the inhalation process has started, on the other hand, the end of the inhalation process is preferably monitored by an app or an electronic device. This monitoring preferably determines whether the inhalation process is complete. Here, the app or electronic device is designed so that repeated triggering action (especially on the screen) or repeated closing action is interpreted as the end of the inhalation process, thereby terminating the inhalation process. It is preferred that a determination be made.

  When it is determined that the inhalation process is completed, it is preferable that the stop time is specified by the application or the electronic device.

  If the end of the inhalation process is not determined by monitoring the end of the inhalation process after a predetermined time (for example, 20 seconds) has elapsed since the start of the prescribed inhalation process, the app or sequence is Preferably it is terminated or aborted. If cancellation is confirmed by the app or the electronic device, the app is terminated. For example, the GUI can be terminated so that it is no longer displayed. Furthermore, the time value can be reset and / or the memory can be released.

  When the stop time is specified, it is preferable that the time keeper is specified by the application or the electronic device. Furthermore, it is preferable to evaluate the electric signal value. Thus, an effective inhalation time and / or inhalation dosage as described above can be determined using, for example, an app or electronic device.

  The result of the evaluation can be displayed on the GUI, and the GUI can be updated accordingly.

  In addition, the app or electronic device may determine when the flow rate determined by the app or electronic device exceeds a value of about 40 liters per minute and / or less than a value of about 20 liters per minute. It is preferable that feedback is given to the three parties, and in particular, a warning display is output.

  If it is determined that the stop instruction has been activated, it is preferable that the GUI is updated and / or the stop is confirmed. The app can also be terminated or stopped by activating a stop instruction (especially on the screen).

Another aspect of the present invention relates to an information storage medium, particularly for portable communication devices. The information storage medium claimed in the present invention stores instructions, which when executed by the processor,
-Initializing the graphical user interface;
-Reading out the electrical signal values of the inhalation training device as described above;
-Digitizing and / or storing electrical signal values;
-Determining an effective inhalation time and / or inhalation dosage;
Is preferably executed.

  The information storage medium claimed in the present invention enables effective, simple, reliable and cost-effective training of the patient's inhalation process.

  Hereinafter, some terms will be described in detail before the description of the drawings.

  The term “inhalation process” in the present invention preferably includes patient inhalation, which can be interrupted over a short time interval and thus can comprise a continuous rapid inspiration. Further, the inhalation process may include air or patient inhalation and / or expiration and / or cough cessation.

  The term “patient” in the context of the present invention refers to an individual who has to use an inhaler and / or wants to use an inhaler, especially an airway disease, in particular asthma or chronic obstructive pulmonary disease. Preferably, it means an individual who is treating a disease using an inhaler.

  The terms “flow” and “air flow” in the present invention are defined as measurable air flow with or without turbulence.

  The above aspects and features of the invention, as well as aspects and features of the invention derived from the further description and claims, can be implemented independently of each other or in any combination.

  Other advantages, features, characteristics and aspects of the invention will become apparent from the claims and from the following description of the preferred embodiments using the drawings.

FIG. 2 schematically shows a perspective view of a preferred embodiment of the inhalation training device in a state before final assembly according to the present invention together with a smartphone. It is a figure which shows schematically the cross section of the housing of the inhalation training apparatus after the assembly of a final housing. It is a figure which shows schematically the cross section of the inhaler which attached the inhalation training apparatus to the mouthpiece of the non-tensile inhaler. FIG. 4 is a diagram schematically showing the inhaler of FIG. 3 rotated about 90 ° in the axial direction in a tension state. 1 schematically shows a perspective view of an inhalation training system according to the invention. FIG.

  In the figures, the same reference numerals are used for the same or similar parts, and corresponding characteristics and advantages are obtained even when repeated descriptions are omitted.

  FIG. 1 schematically shows a perspective view of a preferred embodiment of the inhalation training device in a state before final assembly according to the present invention.

  The inhalation training device 1 is or can be used to train a patient inhalation process (not shown).

  The inhalation training device 1 includes an inhaler 4, specifically, a mouthpiece 3 of a so-called Respirat (registered trademark) inhaler as shown in, for example, International Publication No. 2008/151996, or any other configuration. It includes a housing 2 which is attachable to the part, preferably removable. The inhaler 4 is designed to deliver medication to the patient.

  In a preferred embodiment, the inhalation training device 1 functions only in combination with a specific or limited inhaler 4 such as a Respirat inhaler 4. Specifically, the inhalation training device 1 functions as intended only when attached to the inhaler 4, specifically, to the mouthpiece 3.

  The inhalation training device 1 includes a microphone 5 adapted to measure the air flow that occurs in or into the mouthpiece 3 during the patient's inhalation process.

  In a preferred embodiment, the microphone 5 is an electret microphone.

  The inhalation training device 1 or the microphone 5 is preferably adapted to measure noise in the airflow through the air holes of the inhaler 4 or mouthpiece 3, such as the opening 34 shown in FIG.

  The housing 2 of the inhalation training device 1 preferably comprises or consists of two housing parts 2a, 2b, preferably a lower housing part 2a and an upper housing part 2b.

  The housing 2 or the lower housing part 2a preferably has a holding section or a cylindrical section 2aa which preferably has the shape of a hollow oblique cylinder with an elliptical base. The shape of the section 2aa is preferably similar to or adapted to the shape of the mouthpiece 3 of the inhaler 4 so that it can preferably be pushed onto the mouthpiece 3.

  Specifically, the outer periphery of the cylindrical section 2aa of the lower housing part 2a is larger than the outer periphery of the mouthpiece 3 of the inhaler 4.

  The section 2aa or the lower housing part 2a preferably comprises an outwardly or essentially radial protrusion 2ab.

  The lower housing part 2a preferably includes a finger or cover 2ac protruding from or connected to the cylindrical section 2aa. The finger 2ac is preferably spaced from the protrusion 2ab of the lower housing part 2a along the outer periphery of the cylindrical section 2aa.

  The upper housing part 2b preferably comprises a cylindrical section 2ba having a hollow slanted cylinder shape, preferably having an elliptical base. The outer periphery of the cylindrical section 2ba of the upper housing part 2b is preferably larger than the outer periphery of the cylindrical section 2aa of the lower housing part 2a. The height of the cylindrical section 2ba of the upper housing part 2b is preferably smaller than the height of the cylindrical section 2aa of the lower housing part 2a. The cylindrical section 2ba of the upper housing part 2b preferably includes an outward projection 2bb. Upper housing portion 2b preferably includes a finger or cover 2bc. The finger or cover 2bc preferably protrudes from the cylindrical section 2ba of the upper housing part 2b and / or is spaced from the protrusion 2bb of the upper housing part 2b along the outer periphery of the cylindrical section 2ba of the upper housing part 2b.

  During the assembly of the housing 2, the microphone 5 is mounted in the projecting part 2ac of the lower housing part 2a. From the projecting part 2ac of the lower housing part 2a, the cylindrical section 2aa and the cover 2ac of the lower housing part 2a are attached. A voice cable 6 connected to the microphone 5 is guided along Furthermore, the upper housing part 2b is arranged on the lower housing part 2a, and the two housing parts 2a and 2b are snapped together so that the cylindrical section 2ba of the upper housing part 2b becomes the cylindrical section of the lower housing part 2a. 2a, the protrusion 2bb of the upper housing part 2b covers the protrusion 2ab of the lower housing part 2a, and the cover 2bc of the upper housing part 2b covers the cover 2ac of the lower housing part 2a.

  The housing parts 2a and 2b are preferably connected to each other by a snap fit and / or a molded fit.

  The housing 2 preferably holds or houses the microphone 5 and / or the associated cable 6.

  The microphone 5 is preferably housed between the housing parts 2a and 2b.

  The cable 6 is preferably housed and / or guided between the housing parts 2a, 2b and / or between the sections 2ac, 2bc.

  The inhalation training device 1 or the housing 2 preferably includes a blocking device 2 c that prevents the operation of the inhaler 4. The blocking device 2c is preferably formed by sections 2ac and / or 2bc.

  The blocking device 2c is preferably formed or realized as a finger that covers the blocking element 15 of the inhaler 4, as schematically shown in FIGS.

  The blocking device 2c and / or the sections 2ac, 2bc preferably extend at least partly in the axial direction and / or parallel to the longitudinal direction of the inhaler 4 and / or the longitudinal axis of the housing 2 or the retaining section 2aa.

  The holding section 2aa is adapted to attach the inhalation training device 1 or its housing 2 to the associated inhaler 4, in particular to the mouthpiece 3 of the inhaler 4 or any other component. Most preferably, section 2aa allows mechanical connection to mouthpiece 3 or the like by a press fit.

  The outer shape of the mouthpiece 3 and the inner shape of the section 2aa are slightly tapered towards the free end and can be adapted to achieve the desired tightening when the section 2aa is pushed onto the mouthpiece 3. preferable. However, other forms and / or structural solutions are possible.

  FIG. 2 schematically shows a cross section of the housing 2 of the inhalation training apparatus 1 after the final assembly of the housing 2 but without the microphone 5, the cable 6, and the like.

  Both housing parts 2a, 2b are preferably made of molded plastic with a smooth surface. Therefore, for example, handling noise caused by a patient who trains the inhalation process tracing or scratching the inhalation training apparatus 1 with a finger is reduced. Therefore, the measurement accuracy is improved.

  The inhalation training device 1 provides an interface to the electronic device 7 and / or can be connected to the electronic device 7. In the preferred embodiment of FIG. 1, the electronic device 7 is a smartphone.

  In a preferred embodiment, the interface and / or connection to the electrical device 7 is preferably realized by a cable 6 and / or a connector 8, such as an audio jack, in particular a 3.5 mm TRRS headphone connector.

  Since the 3.5 mm TRRS headphone connector 8 is the most common smartphone connector in the world, it is preferable that the inhalation training apparatus 1 has compatibility with various smartphones and only one deformation is required. This allows patient comfort and cost-effective inhalation process training, and patient-friendly real-time feedback.

  In addition to this, or alternatively, the inhalation training device 1 can be wirelessly connected to the electric device 7 via Bluetooth (registered trademark) or the like.

  In a preferred embodiment, the inhalation training device 1 includes an electronic device 5a (shown in FIGS. 1 and 3) configured to process any microphone signal and / or generate a reference sound during training. Therefore, this reference sound always occurs with the signal of the microphone 5, making a known reference available.

  Specifically, this reference sound is implemented by mounting a precise oscillator having a clearly defined frequency of about 10 kHz and preferably an amplitude of 1.2 V in the electronic device 5a of the inhalation training apparatus 1 to obtain the reference sound as a microphone signal. It is preferable to realize the mixing.

  FIG. 3 schematically shows a cross section of the inhaler 4 in which the inhaler training apparatus 1 is attached to the mouthpiece 3 of the inhaler 4. FIG. 4 also schematically shows a cross section of the inhaler 4 in which the inhaler training apparatus 1 is attached to the mouthpiece 3 of the inhaler 4. It is rotated 90 °.

  The two housing parts 2a, 2b are preferably designed to fit together exactly and fit securely onto the mouthpiece 3 of the inhaler 4. This reliably minimizes leakage between the mouthpiece 3 of the inhaler 4 and the housing 2 of the inhalation training device 1. Accordingly, high measurement accuracy and high mechanical stability are realized. At the same time, the housing 2 has a suitable space inside for accommodating and protecting the microphone 5, the audio cable 6 and the further electronic device 5a.

  Furthermore, the design of the housing 2 described, in particular the section 2aa and the non-circular cross-section of the mouthpiece 3, prevents the housing 2 from being positioned incorrectly when attached to the mouthpiece 3 of the inhaler 4.

  In the preferred embodiment shown, the housing 2 is designed to prevent drug release during training. Specifically, when the inhalation training device 1 is attached to the mouthpiece 3 of the inhaler 4, the blocking device 2 c or the covers 2 ac and 2 bc of the two housing parts 2 a and 2 b are released from the medicine such as the blocking element 15 of the inhaler 4. Cover the actuator.

  When the inhalation training apparatus 1 is attached to the mouthpiece 3 of the inhaler 4, the microphone 5 is located outside the mouthpiece 3 of the inhaler 4 and / or near the air hole or opening 34 of the mouthpiece 3 of the inhaler 4. Preferably it is automatically positioned. This allows accurate flow measurement without having to intervene in the function of the inhaler 4, or allows fluid flow in the mouthpiece 3 without having to change the design of the inhaler 4. The aerodynamic behavior of the flow path of the inhaler 4 is preferably not changed by the inhalation training device 1. By doing so, the medical adaptability of the inhaler 4 is not affected by the presence (or absence) of the inhalation training device 1.

  Measurements are made using a calibrated Tetratec ™ flow meter, using a single inhaler 4 followed by the same inhaler 4 with the inhalation training device 1 mounted on the mouthpiece 3 of the inhaler 4 And compared. In both situations, the flow resistance of the tube connected to the mouthpiece 3 (not covering the air holes) was measured. As a result of the measurement, it was found that the air flow was not restricted by the presence of the inhalation training device 1. The flow resistance when using the inhalation training device 1 is unchanged compared to a single inhaler 4, which confirms that it is not necessary to train a patient with another type of inhalation experience.

  Hereinafter, the inhaler 4 will be described in more detail.

  The inhaler 4 is shown schematically in a non-tensioned state (FIG. 3) and a tensioned state (FIG. 4) and is designed to atomize a fluid 9, specifically a highly effective pharmaceutical composition, drug, etc. The The inhaler 4 is specifically configured as a portable inhaler and preferably operates only mechanically and / or without propellant gas.

  The inhaler 4 has or includes an insertable or replaceable container 10 containing a fluid 9. The container 10 thus forms a reservoir for the fluid 9 to be atomised. The container 10 may contain a plurality of doses, in particular sufficient fluid 9 or active substance to carry out, for example, up to 200 dose units or doses, ie up to 200 sprays or sprays. preferable. A typical container 10 as disclosed in WO 1996/006011 holds a volume of, for example, about 2-20 ml.

  It should be noted that the dosage can vary depending on the fluid 9 or the drug. The inhaler 4 can be adapted to each.

  Furthermore, the number of doses contained in the container 10 and / or the total volume of the fluid 9 contained in the container 10 may also vary depending on the fluid 9 or respective medicament and / or the container 10 and / or the required dosage. .

  The containers 10 are preferably replaceable or exchangeable, and the number of containers 10 that can be used in the same inhaler 4 is preferably limited to, for example, four or five containers 10 in total.

  The container 10 is preferably substantially cylindrical or cartridge-shaped, and when the inhaler 4 is opened, the container 10 is preferably inserted from the lower side, and can be replaced as necessary. The container is rigid and the fluid 9 is preferably held in a collapsible bag 11 in the container 10. Specifically, the container 10 includes a vent opening or hole 30 that is opened before or during initial use.

  The inhaler 4 includes a delivery mechanism, preferably a pressure generator 12, which carries and atomizes a fluid 9, specifically a preset amount of an arbitrarily adjustable dose.

  The inhaler 4 or the pressure generator 12 is preferably a holder 13 for releasably holding the container 10, a drive spring 14 showing only a part associated with the holder 13, and / or preferably for manual actuation or pressing, preferably It is preferable to include a blocking element 15 in the form of a button or having such a button. The blocking element 15 can capture and block the holder 13 and can be manually operated to release the holder 13 and allow the drive spring 14 to expand.

  The inhaler 4 or the pressure generator 12 preferably includes a transmission element such as a transmission tube 16, a check valve 17, a pressure chamber 18, and / or a nozzle 19 that atomizes the fluid 9 into the mouthpiece 3.

  The fully inserted container 10 is fixed or held in the inhaler 4 via the holder 13 so that the transmission element fluidly connects the container 10 to the inhaler 4 or the pressure generator 12. The transmission tube 16 preferably enters the container 10.

  The inhaler 4 or the holder 13 is preferably configured so that the container 10 can be replaced.

  When the drive spring 14 is pulled in the axial direction in the tensioning process, the container 10, the holder 13, and the transmission pipe 16 move downward in the drawing, and the fluid 9 flows from the container 10 through the check valve 17 to the pressure of the pressure generator 12. Inhaled into chamber 18. In this state, the holder 13 is captured by the blocking element 15 and the drive spring 14 is held in a compressed state. At this time, the inhaler 4 is in a tensile state.

  If the blocking element 15 can be actuated or pressed (as opposed to attaching the inhalation training device 1 to the inhaler 4), relaxation follows in the atomization process, during which time the check valve 17 The transmission tube 16 is closed in the pressure chamber 18 upwardly in the drawing due to the relaxation or force of the drive spring 14 and acts as a pressing ram or piston, so that the fluid 9 in the pressure chamber 18 is under pressure. Will be put on. This pressure forces the fluid 9 into the nozzle 19 so that the fluid 9 is atomized into an aerosol and dispensed.

  In general, the inhaler 4 is in a state where a spring pressure of 5 to 200 MPa, preferably 10 to 100 MPa is applied to the fluid 2 and / or 10 to 50 μl, preferably 10 to 20 μl, most preferably per stroke. Operate with approximately 15 μl of fluid 2 volume delivered. The fluid 9 is converted to an aerosol or atomized as an aerosol, the droplets having an aerodynamic diameter of up to 20 μm, preferably 3 to 10 μm. The generated jet spray preferably has an angle of 20 ° to 160 °, preferably 80 ° to 100 °.

  The inhaler 4 includes a housing 31 and / or (upper) housing part 23 and is preferably rotatable relative to the housing 31 and / or (upper) housing part 23 (FIG. 4) and / or an upper part 24a and It is preferred to optionally include a biasing or inner portion 24 having a lower portion 24b (FIG. 3).

  The inhaler 4 or the housing 31 preferably includes a (lower) housing part 25. This portion 25 is in particular preferably manually operable and / or releasably fixed and preferably attached or held to the inner portion 24 by a holding element 26.

  The housing parts 23 and 25 and / or other parts preferably form the housing 31 of the inhaler 4.

  Preferably, the housing 31 can be opened and / or the housing part 25 can be separated from the inhaler 4, the inner part 24 or the housing 31 in order to insert and / or replace the container 10.

  In general, the container 10 is preferably insertable before closing the housing 31 and / or before connecting the housing portion 25 to the housing 31. The container 10 is inserted and opened automatically or simultaneously when the housing part 25 is connected (completely) to the housing 31 / inhaler 4 and / or when the housing 31 / inhaler 4 is (completely) closed, And / or preferably fluidly connected to the delivery mechanism.

  The inhaler 4 or the drive spring 14 can be actuated or pulled manually, in particular by actuation of the actuating member, here preferably by rotating the housing 25 or any other component.

  The actuating member, preferably the housing part 25, can be actuated relative to the upper housing part 23, where it can be rotated to carry or drive the inner part 24 together. The inner portion 24 acts on the gear or power transmission to convert rotation into axial movement. As a result, the drive spring 14 is pulled in the axial direction by a gear or a power transmission portion (not shown) that is formed between the inner portion 24, specifically, the upper portion 24 a and the holder 13 and acts on the holder 13. become. During pulling, the container 10 moves downward in the axial direction until an end position as shown in FIG. 4 is taken. In this actuated or tensioned state, the drive spring 14 is under tension and can be captured or held by the blocking element 15. During the atomization process, the container 10 returns to its original position (non-tension position or state shown in FIG. 3) by the drive spring 14 (its force). Accordingly, the container 10 performs an up / down movement or a stroke movement during the tensioning process and the spraying process.

  The housing part 25 preferably forms a cap-shaped lower housing part and / or fits around or covers the lower free end of the container 10. When the drive spring 14 is pulled, the container 10 and its end move (further) into the housing part 25 or towards its end surface, while aeration means such as an axially acting spring 27 arranged in the housing part 25 are present. When contacting the base 28 of the container 10 and when the container 3 contacts the penetrating element 22 for the first time, the penetrating element 22 penetrates the container 3 or the base seal or the foil 50 thereon, preferably opening the vent 23 or Perforation allows air introduction or aeration.

  The inhaler 4 preferably includes an indicator device 25 that specifically counts the operation of the inhaler 4 by detecting the tension or rotation 24 of the inhaler 4 relative to the upper part 23 or the housing 31. The counter device 32 or the associated locking device 33 may, for example, further rotate the housing part 25 / inner part 24 and thus the inhaler 4 or drive it when a certain number of actuations or actuations or administrations is reached or exceeded. Preferably, the tension of the spring 14 is prevented and / or the actuating of the blocking element 15 is prevented to lock the inhaler 4 in a locked state for (further) actuation or use.

  The inhaler 4 is designed to be portable unlike an independent facility or the like, and specifically, is preferably a mobile manual operation device.

  The fluid 9 is preferably an aqueous pharmaceutical preparation or an ethanol pharmaceutical preparation. On the other hand, the fluid 9 can be any other pharmaceutical preparation, suspension, or the like.

  Alternatively, the fluid 9 can include particles or powder. In this case, in place of the discharge nozzle 17, some other type of supply device, in particular, a discharge opening (not shown) or a supply path (not shown) for supplying fluid or powder into the mouthpiece 3 is provided. be able to. In this case, ambient air is preferably at the same time so that any air supply opening (not shown) generates or allows a volume of air flow sufficient for exhalation in the mouthpiece 3 or inhalation through the mouthpiece 3. Play a role to supply.

  If necessary, the fluid 9 can be atomized with propellant gas.

  Preferably, the preferred components and / or formulations of the drug fluid 9 are specifically described in WO 2009/115200, preferably on pages 25-40, or in EP 261848, paragraphs 0040-0087, These documents are incorporated herein by reference. Specifically, these components and / or formulations can be aqueous or non-aqueous solutions, mixtures, formulations containing ethanol or no solvent, and the like.

  FIG. 5 schematically shows a perspective view of a preferred embodiment of an inhalation training system 35 according to the present invention.

  The inhalation training system 35 is used, usable or designed to train a patient's inhalation process.

  The inhalation training system 35 includes an inhalation training device 1 as described above, preferably an inhaler 4 as described above, and a separate and / or mobile electronic device 7, preferably a smartphone.

  The smartphone 7 is configured to evaluate a signal received from the inhalation training device 1 and specifically provide visual and / or audio feedback to the patient via the display 7a or the speaker 7b.

  The purpose of the inhalation training system 35 is to further educate the patient to perform correct inhalation using various inhalers. Some patients have previously used other inhalers (eg, passive powder inhalers) that specifically require a strong inhalation for only a short period of time, so 1-1. Proper use due to the preferred soft mist technology of the inhaler that produces a homogeneous droplet-like aerosol cloud lasting 5 seconds and instructing correct inhalation to inhale at a relatively low flow rate over a long period of time It can be confusing.

  The inhalation training system 35 provides effective, simple, reliable, comfortable and cost-effective training of the patient's inhalation process, accurate measurement of the flow generated by the patient during training, and patient-friendly real-time feedback. to enable.

  In a preferred embodiment, the inhalation training system 35 non-invasively (ie, an inhaler) delivers a correct inhalation flow of at least 20-40 l / min with an accuracy of at least ± 50%, preferably better than ± 20%. 4) using a constant flow resistance of 4).

  The electronic device 7 is preferably configured to detect the presence of the inhalation training device 1 through the reference sound as described above generated by the inhalation training device 1 during training. Therefore, the electronic device 7 can detect whether the inhalation training device 1 is inserted into the electronic device 7 via the connector 8. Otherwise, the electronic device 7 is configured not to provide feedback regarding flow detection.

  The electronic device 7 can be interfaced with the external microphone 5 of the inhalation training device 1.

  In a preferred embodiment, the electronic device 7 is equipped with a dedicated app that collaborates on real-time measurements and information display (preferably via the display 7a) on the patient's inhalation flow to ensure correct inhalation technology. And provide feedback regarding incorrect inhalation techniques.

  This app provides the patient with flow feedback in a simple and intuitive (non-scientific) manner and can be downloaded to the electronic device 7. For this purpose, the app is developed for all main platforms, in particular for iOS and Android.

  The app targets a wide range of patients, even if it is developed to include all the technical analysis capabilities described above, and thus utilizes a very simple and intuitive user interface. The app and / or electronic device 7 preferably shows one or more respective symbols 7 such as balloons that are easily understandable via the display 7a of the electronic device 7 and / or most preferably most people. Is preferably adapted to provide audible and / or visual feedback (by way of example, compare FIG. 5 showing a balloon as symbol 7d indicating inhalation process etc.).

  Specifically, the balloon concept was ultimately chosen as the core element for providing feedback on the patient's inhalation flow pattern. According to this concept, the flight level of the balloon is determined by the inhalation flow rate of the patient. If a patent makes a powerful inhalation (eg, over 60 l / min), the balloon will soar high on the screen, and if the inhalation is very weak (eg <10 l / min), the balloon will wander across the bottom of the screen Become. In the central range of 20-40 l / min, the balloon changes from red (dark blue) to green and the two arrows begin to close from the side. After 2 seconds of correct flow, the arrow bursts the balloon, indicating that it has successfully inhaled. When the balloon breaks, the screen switches to a 10-second countdown clock, allowing training to stop breathing after inhalation (similar to instructions for use).

  The app is divided into two parts, a passive guide part and an active training part, where the patient is carefully guided before taking the actual training.

  The patient first accepts the terms of service and then starts the app's guide part, attaches the inhalation training device 1 onto the mouthpiece 3 of the inhaler 4 and plugs the connector 8 into the electronic device 7. Perform patient-related introduction steps. Patients are introduced to the features of the app using both an animated screen with balloons flying and an animated screen holding their breath. The patient can exit the guide and start training by pressing the highlighted “X” at any point in the guide, otherwise simply check the “Start Training” button on the last page of the guide Will lead you back to the training part of the app. Upon entering the training portion, the app requires the presence of the inhalation training device 1 to function. If the inhalation training device 1 is not attached, a warning is given to the patient.

  In general, the user or patient can also press the button 7c, screen, etc. of the electronic device 7 for input or confirmation purposes.

  Thereafter, inhalation is performed through the inhalation training device 1 mounted on the inhaler 4, and flow training is performed by completing the goal of holding the balloon in the “green” zone for 2 seconds and then holding the breath for 10 seconds. When both steps are completed successfully, a green symbol jumps into the history bar indicating the last 5 attempts. The app has no means to detect that the patient is holding his breath, so the last step of this training sequence cannot otherwise disqualify the complete inhalation sequence and the history Only the final result added to waits for 10 seconds.

  The main training goal of the inhalation training device 1 is to help the patient reduce the inhalation flow to a level much lower than that required for passive DPI, for example, so that the patient is 2 seconds (or longer) If the inhalation is excessively strong (above 40 l / min), it is one factor that can cause unsuccessful inhalation. In this situation, the inhalation sequence is unsuccessful and a negative result is added directly to the history without performing a breath-holding sequence.

  Patients are encouraged to continue training until the balloon balance can be safely and reliably maintained each time (over at least 5 consecutive trials), regardless of success or failure. The option “Challenge again” is presented.

  Preferably, instructions are stored on the information storage medium that, when executed by the processor, cause the steps described above to be performed.

  Other steps can be added to the described app steps. You can also skip individual steps in the app. It is also possible to change the sequence of individual steps and to combine different steps with each other. Individual steps of the app can also be implemented independently of other steps.

  The accuracy of the flow rate measurement also depends on the manufacturing tolerances of the microphone 5 that may exhibit ± 3 dB variation in acoustic sensitivity. Even if there are no other error factors, such variation in microphone tolerance is converted to a measurement uncertainty of about ± 35%. This uncertainty does not appear to be very important in performing the inhalation training process, for example, there is no problem if a measurement uncertainty of ± 50% is communicated.

  To mitigate microphone tolerance variations, the microphone gain and / or reference sound amplitude can be calibrated. Each electronic device module including the microphone 5 is preferably subjected to a test using a reference acoustic signal that can be evaluated for variations from the ideal reference (before being installed in the housing 2 of the inhalation training device 1). If so, for example, the reference sound amplitude is adjusted to produce the desired relationship with the measured microphone signal. Adjustment can be as simple as cutting a wire on a flexible printed circuit board for transport (eg, cutting a parallel resistor that controls the reference voltage decay).

  Alternatively, the finally assembled inhalation training device 1 can be tested to generate a code based on individual acoustic deviations. This code can then be imported into the app before use. For example, the inhalation training device 1 can have an individual serial number including a one-digit reference symbol for classifying the inhalation training device 1. The patient can manually enter the code when starting the app to increase measurement accuracy. Alternatively, a barcode can be printed on the housing 2 of the inhalation training device 1. The patient can then scan the barcode using the smartphone 7 camera during the app initialization procedure.

  FIG. 5 shows another preferred embodiment of the present invention. The inhalation training device or its housing 2 includes a blocking device 2c that prevents any dispensing of the fluid 9 by the inhaler 4 when the inhalation training device 1 is attached to or has the inhaler 4. Is preferred. The blocking device 2c preferably covers an operating element or button such as the blocking element 15 of the inhaler 4 in order to block or prevent any possible actuation and thus any possible dispensing of the fluid 9. However, other structural solutions are possible.

  The inhalation training device 1 preferably does not (significantly) modify or limit the air flow drawn into the mouthpiece 3 through at least one opening 34 during inhalation. However, the microphone 5 can project into the associated opening 34 and / or is preferably located adjacent to one ventilation opening 34 and most preferably as close as possible to the ventilation opening 34.

  In this embodiment, the inhalation training device 1 or its housing 2 does not cover the other opening 34. For this purpose, the inhalation training device 1 or the housing 2 preferably includes a recess 2d as shown in FIGS.

  The inhalation training device 1 or its housing 2 has at least one as schematically shown in FIGS. 1 and 3 so as not to restrict the air flow sucked into the mouthpiece 3 through the opening (s) 34 during inhalation. It is preferable to include the supply opening 2e and the like.

  The cable 6 is preferably guided in the inhalation training device 1 or its housing 2 from the mouthpiece 3 to the other end of the inhaler 4, preferably through a blocking device 2c, and / or part or section 2ac and / or It is preferable that the thickness is reduced in the same manner as 2bc.

  The microphone 5 and the electronic device 5a preferably form a unit or assembly. Specifically, the electronic device 5a is integrated with the microphone 5, or the microphone 5 is integrated with the electronic device 5a.

  The training inhaler 1 or its housing 2 preferably holds the microphone 5 and / or the unit or assembly of the electronic device 5a by a snap fit and / or a molded fit. FIG. 3 schematically shows a possible implementation. For example, the unit or assembly can be inserted or inserted into the holding recess 2f or the like, or preferably the microphone 5 faces the mouthpiece 3, adjacent to the ventilation opening 34 and / or inhaler. 4 nozzles 19 and / or mounted radially inward.

  The blocking device 2c is preferably supported against or abuts against the inhaler housing 31 of the inhaler 4, preferably the upper housing part 23. For this purpose, the blocking device 2c or section 2ac can include respective protrusions or contact portions 2ca as shown in FIGS.

  The blocking device 2c is a blocking element that ensures that any dispensing of fluid 9 from the inhaler 4 is reliably prevented when the inhalation training device 1 is attached to the inhaler 4 or the inhaler 4 is attached to the inhalation training device 1. 15 or any other actuating element necessary to trigger or initiate the dispensing of fluid 9 from the nebulizer 4 is preferably completely covered.

DESCRIPTION OF SYMBOLS 1 Inhalation training apparatus 2 1 housing 2a Lower housing part 2aa 2a cylindrical section 2ab 2a protrusion 2ac 2a cover 2b Upper housing part 2ba 2b cylindrical section 2bb 2b protrusion 2bc 2b cover 2c blocking device 2ca contact portion 2d recess 2e opening 2f holding recess 3 mouthpiece 4 inhaler 5 microphone 5a electronic device 6 cable 7 electronic device 7a display 7b speaker 7c button 7d symbol 8 headphone connector 9 fluid 10 container 11 bag 12 pressure generator 13 holder 14 Drive spring 15 Blocking element 16 Transmission pipe 17 Check valve 18 Pressure chamber 19 Nozzle 23 Upper housing part 24 Inner part 24a Inner part upper part 24b Inner part lower part 25 Housing part (lower part)
26 holding element 27 aeration spring 28 container base 29 penetrating element 30 vent hole 31 inhaler housing 32 indicator device 33 locking device 34 opening 35 inhalation training system

Claims (15)

An inhalation training device (1) for training a patient's inhalation process,
A housing (2) that is attachable to and preferably removable from the mouthpiece (3) of an inhaler (4) designed to deliver medication to the patient;
A microphone (5) adapted to measure the air flow generated in the mouthpiece (3) of the inhaler (1) during the inhalation process of the patient;
With
The housing (2) is snapped together and / or holds the microphone (5) and / or holds the associated electronics (5a) and / or holds the associated cable (6) Two housing parts (2a, 2b)
The microphone (5) is located inside the housing (2) or outside the mouthpiece (3) in the housing (2) when the inhalation training device (1) is attached to the mouthpiece (3). And / or outside the air hole (34) or nozzle (19) of the mouthpiece (3) or the inhaler (4) and / or adjacent to the air hole (34) or nozzle (19). Position to,
The housing (2) is specifically designed to prevent drug release during training by a finger-like blocking device (2c), preferably covering the actuating element or blocking element (15) of the inhaler (4). Designed,
An inhalation training device. Both housing parts (2a, 2b) are made of molded plastic with a smooth surface, specifically acrylonitrile butadiene styrene, and / or both housing parts (2a, 2b) are low friction layers, specifically Is at least partially coated with shiny chrome,
The inhalation training device according to claim 1. The housing (2) includes a molded parting line for hermetic attachment to the mouthpiece (3),
The inhalation training apparatus according to claim 1 or 2. The housing (2) includes a pad and / or sleeve around the microphone (5), specifically made of foamed plastic or soft silicone,
The inhalation training device according to any one of claims 1 to 3. The microphone (5) is an electret microphone and / or the microphone (5) is adapted to measure noise of the air flow through the air holes of the mouthpiece (3);
The inhalation training device according to any one of claims 1 to 4. The microphone (5) exhibits directivity, specifically, cardioid, super cardioid, hyper cardioid, or bidirectional characteristics.
The inhalation training device according to any one of claims 1 to 5. The inhalation training device (1) specifically provides an interface with an electronic device (7) via a connector (8) such as an audio jack, in particular a 3.5mm TRRS headphone connector,
The inhalation training device according to any one of claims 1 to 6. The inhalation training device (1) includes an electronic device (5a) configured to replace the electrical connection with the microphone and ground according to a connection scheme of the TRRS headphone connector.
The inhalation training device according to claim 7. The inhalation training device (1) comprises an electronic device (5a) configured to adjust the frequency range in which the microphone (5) operates as a function of the analog front end sensitivity of the electronic device (7).
The inhalation training device according to any one of claims 1 to 8. The inhalation training device (1) comprises an electronic device (5a) configured to generate a reference sound during training, in particular the electronic device (5a) is particularly a reference sound with a frequency of 10 kHz. Including an oscillator that can generate
The inhalation training device according to any one of claims 1 to 9. The housing (2) is designed to prevent mispositioning of the housing (2) or guide means or position that provides a clear positioning of the housing (2) when attached to the mouthpiece (3) Having a matching means,
The inhalation training device according to any one of claims 1 to 10. An inhalation training system (35) for training a patient's inhalation process,
Inhalation training device (1) according to any one of claims 1 to 11,
An inhaler (4);
An electronic device (7) configured to evaluate signals received from the inhalation training device (1) and provide visual and / or audio feedback to the patient;
An inhalation training system comprising: The inhalation training system (35) is configured to detect the presence of exhalation of the patient during training;
The inhalation training system according to claim 12. The electronic device (7) is configured to detect the presence of a characteristic audio signal in the signal received from the inhalation training device 1;
The inhalation training system according to claim 12 or 13. The electronic device (7) is specifically configured to detect the presence of a particular type of the inhaler (4) by means of a reference sound produced during training by the inhalation training device (1).
The inhalation training system according to claim 13 or 14.

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